Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors

OBJECTIVES:

Primary

• Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when given in combination with docetaxel in patients with advanced solid tumors.

Secondary

• Determine the safety of this regimen in these patients.
• Determine the objective tumor response in patients treated with this regimen.
• Determine the time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of lenalidomide.

Patients receive oral lenalidomide on days 1-14 and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor

• Advanced disease
• Refractory to standard therapy OR no standard therapy exists
• Measurable or evaluable disease
• No active brain metastases

• Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed provided they are currently asymptomatic and inactive by CT scan or MRI

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• At least 4 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8 g/dL

Hepatic

• Bilirubin normal
• Meets 1 of the following criteria:

• Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
• AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
• AP ≤ 5 times ULN AND AST or ALT normal

Renal

• Creatinine ≤ 2 mg/dL

Cardiovascular

• No New York Heart Association class III or IV heart disease

Immunologic

• No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide
• No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
• No history of allergic reaction to compounds of similar chemical or biologic composition to study drugs

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other uncontrolled illness or other condition that would preclude study compliance
• No peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent hematopoietic growth factors during course 1 of study treatment
• No concurrent immunotherapy

Chemotherapy

• At least 6 weeks since prior mitomycin or nitrosoureas

• No more than 2 prior courses of mitomycin
• No other concurrent chemotherapy

Radiotherapy

• No prior pelvic radiotherapy

Other

• At least 4 weeks since prior anticancer therapy
• No concurrent warfarin for anticoagulation (heparin is allowed)
• Recovered from all prior treatment
• No other concurrent anticancer therapy except bisphosphonates
• No other concurrent investigational agents